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InterMune Reports Second Quarter 2009 Financial Results and Business Highlights
Date:8/6/2009

ucted by Shionogi & Co. Ltd. in Japan.
  • Pirfenidone was safe and generally well tolerated in both CAPACITY studies. There was no difference in SAEs and fewer deaths were observed with pirfenidone compared to placebo. Adverse events were comparable to previous clinical studies of pirfenidone.
  • New, pre-specified exploratory efficacy data from CAPACITY pertaining to dose-effect relationships, mean change in FVC volume and Six-Minute Walk Test distance that was presented provided valuable insight into the estimate of treatment effect in the combined populations.
  • ITMN-191:

    • InterMune announced today the successful completion of chronic toxicology studies in two specific species: a six-month chronic toxicology study in rats and a nine-month chronic toxicology study in monkeys. There were no significant drug-related findings in either study. These results provide the necessary preclinical data to conduct the intended Phase 2 and Phase 3 clinical programs for ITMN-191.
    • InterMune expects that the first patient will be enrolled in August in the Phase 2b study of ITMN-191 in combination with standard of care. The Phase 2b trial will study both twice-daily (600mg and 900mg q12h) and three-times-daily regimens (300mg q8h) and both 12-week and 24-week treatment durations.
    • InterMune and its collaboration partner Roche announced today their plan to initiate during the third quarter, a Phase 1b multiple-ascending-dose (MAD) study of once-daily and twice-daily ITMN-191 co-administered with a low dose of ritonavir in combination with standard dose Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) in HCV-infected patients. Ritonavir is an antiviral compound commonly used at low doses to enhance or "boost" the pharmacokinetic (PK) profiles of several marketed HIV protease inhibitors and at least one
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    SOURCE InterMune, Inc.
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